PD-L1, IHC (Pembrolizumab)

CPT: 88360
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Test Details

Synonyms

  • Keytruda®
  • Programmed Death Ligand 1

Use

The Dako PD-L1 22C3 pharmDx™ kit is a qualitative assay intended for use in the detection of PD-L1 in formalin-fixed, paraffin-embedded (FFPE) in non−small-cell lung carcinoma (NSCLC) using the Dako Autostainer Link 48 platform.

Methodology

Immunohistochemistry (IHC) using Dako Autostainer Link 48 platform.

Specimen Requirements

Specimen

Formalin-fixed, paraffin-embedded (FFPE) tissue block or slides

Volume

At least three unstained slides sectioned at 4 to 5 microns, less than one month in age. Five slides are ideal.

Minimum Volume

Three unstained slides

Container

Paraffin block or unstained positive-charged slides

Collection

Paraffin block or unstained slides sectioned of no more than one month age.

Storage Instructions

Refrigerate, protect from light.

Causes for Rejection

Slides sectioned greater than one month prior to test request

Clinical Information

Special Instructions

PD-L1 testing will be delayed if the pathology report is not received.

Note: This test number is used for tracking oncology IHC specimens to the laboratory. Bill codes will be added when testing is complete, based on the processes performed in the laboratory.

References

Garon EB, Rizvi NA, Hui R, et al. Pembrolizumab for the treatment of non−small-cell lung cancer. N Engl J Med. 2015 May 21; 372(21):2018-2028. 25891174
PD-L1 IHC 22C3 pharmDx™ [package insert]. P02893 rev04 IUO IFU. Carpinteria, Calif: Dako; 2014:1-6.

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
451852 PD-L1 IHC, KEYTRUDA(R) 85147-7 451839 Result 83052-1
451852 PD-L1 IHC, KEYTRUDA(R) 85147-7 451847 % Tumor Cells Staining: % 83053-9
451852 PD-L1 IHC, KEYTRUDA(R) 85147-7 451848 Comments: 77202-0
451852 PD-L1 IHC, KEYTRUDA(R) 85147-7 451849 Interpretation 77202-0
451852 PD-L1 IHC, KEYTRUDA(R) 85147-7 451851 Director Review 72486-4
451852 PD-L1 IHC, KEYTRUDA(R) 85147-7 452103 Bill Code Entry Hold N/A

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CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2018, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf